Elekta, Inc. Elekta Unity, Image-Guided Radiation Therapy System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elekta Unity, Image-Guided Radiation Therapy System
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035
Products Sold
Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035
Elekta, Inc. is recalling Elekta Unity, Image-Guided Radiation Therapy System due to There have been reports of excessive heating in the MRL Gradient Connection Module.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There have been reports of excessive heating in the MRL Gradient Connection Module.
Recommended Action
Per FDA guidance
Initially, the firm issued an email on 12/18/2019 to their field engineers which said they had attached a "Knowledge Article" which provided instructions on how to inspect the Philips Marlin 1.5T system used in the Elekta Unity MR Linac. On 5/11/2020, the firm issued an Urgent Important Field Safety Notification dated May, 2020, via email to consignees which explained the problem, clinical impact, and said that initial corrective actions have been performed on all impacted sites to ensure the gradient coil connection assembly is correct. It goes onto say that extensive testing of the incorrect connection material has been completed to ensure that continued use of the Elekta Unity system is acceptable, however, it remained that further actions can be taken to reduce the risk.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, IA, NY, PA
Page updated: Jan 10, 2026